Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
162361–162384 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 31, 1981
AIR MATTRESS
K813407 · FNM
Trans World Agency, Inc.
General Hospital · 24d
Cleared Dec 31, 1981
GLUCOSE ENZYME-COLOR REAGENT SET
K813412 · CGA
Diagnostic Specialties
Chemistry · 27d
Cleared Dec 31, 1981
PEAK FLOW MONITOR
K813414 · BZH
Biotrine Corp.
Anesthesiology · 24d
Cleared Dec 31, 1981
UREA NITROGEN REAGENT SET
K813415 · CDW
Anco Medical Reagents & Assoc.
Chemistry · 24d
Cleared Dec 31, 1981
ULTRACHEM GLUC-DH
K813427 · LFR
Harleco
Chemistry · 24d
Cleared Dec 31, 1981
SHUNT ADAPTER
K813428 · FKN
Quinton, Inc.
Gastroenterology & Urology · 23d
Cleared Dec 31, 1981
PAN SET
K813437 · FRG
Sterile Design, Inc.
General Hospital · 23d
Cleared Dec 31, 1981
PIPERACILLIN 100 MCG. SENSI DISC
K813441 · JTN
Bd Becton Dickinson Vacutainer...
Microbiology · 21d
Cleared Dec 31, 1981
SOLUTIONS & BUFFERS FOR BLOOD GAS INSTR
K813447 · JIS
Rna Medical Corp.
Chemistry · 30d
Cleared Dec 31, 1981
PHE/TYR KINETIC UV TEST SET
K813449 · JNB
P-L Biochemicals, Inc.
Chemistry · 21d
Cleared Dec 31, 1981
FREE T4 RIA TEST SET
K813465 · CEC
Ventrex Laboratories, Inc.
Chemistry · 20d
Cleared Dec 31, 1981
LIPID PROFILE
K813469 · CFD
Bio-Analytics Laboratories, Inc.
Chemistry · 20d
Cleared Dec 31, 1981
OHIO VOLUME INCENTIVE SPIROMETER
K813476 · BWF
Airco/Ohio Medical Products
Anesthesiology · 30d
Cleared Dec 31, 1981
CATHETER BUBBLE STAND
K813487 · FKX
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Dec 31, 1981
CATHETER REGULAR
K813488 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Dec 31, 1981
WATERS ILEAL RESERVOIR CATHETER
K813494 · KPH
Waters Instruments, Inc.
Gastroenterology & Urology · 17d
Cleared Dec 31, 1981
ALT (SGPT)
K813495 · CKA
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Dec 31, 1981
LDH-L
K813496 · CFJ
Pointe Scientific, Inc.,
Chemistry · 17d
Cleared Dec 31, 1981
FLAME PHOTOMETER CALIBRATION STANDARDS
K813505 · JIS
Fisher Scientific Co., LLC
Chemistry · 16d
Cleared Dec 31, 1981
METRONIDAZOLE DIAGNOSTIC DISCS
K813509 · JTO
Oxoid U.S.A., Inc.
Microbiology · 16d
Cleared Dec 31, 1981
URIC-ACID
K813511 · KNK
Medical Analysis Systems, Inc.
Chemistry · 16d
Cleared Dec 31, 1981
AFRICAN GREEN MONKEY BLOOD IN ALSERVERS
K813513 · LHW
Dutchland Laboratories, Inc.
Pathology · 16d
Cleared Dec 31, 1981
BLOOD GAS ANALYSIS, STANDARDS CONTROLS
K813517 · CHL
United Diagnostics, Inc.
Chemistry · 15d
Cleared Dec 31, 1981
ELECTRIC SELF STERILIZATION INOCUL. LOOP
K813523 · LTB
Techhnilab Instruments, Inc.
Toxicology · 15d